MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number M0-43

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Patient-Device Incompatibility (2682)

Patient Problems Reaction (2414); Burn, Thermal (2530)

Event Date 05/13/2019

Event Type  Injury  

Event Description

Alarm exploded 30 mins into use and hurt son ((b)(6) y/o) in his neck.The cause of the explosion was defect in the alarm.Batteries also leaked out of the device and spread on his skin causing allergic reaction.Combination of heat from alarm and battery leak burnt him and he had to be taken to the clinic for treatment.Fda safety report id# (b)(4).

• Brand Name: MALEM ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8624021
• MDR Text Key: 145674600
• Report Number: MW5086745
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M0-43
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 18